MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAW ROUND 38.9*Ø5 Ø0.6 F/PIEZOELECTRIC S; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 03.000.424S

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The part number is unknown.Therefore, the gtin is unknown.A udi cannot be generated.The product code is unknown.Therefore, the brand name, common device name, catalog number and 510k classification are unknown.The manufacturing location was unknown.The lot number was unknown; therefore, the manufacture date is unknown.Reporter¿s phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during rhinoplasty, it was observed that there was de-epithelization of the skin on the left side of the nose while using the saw device to take down the dorsal hump.According to the report, the saw device was being used with the irrigation tubing device that appeared to be working appropriately.The surgeon was very surprised that there was a soft tissue injury that resulted in a full thickness burn on the side of the nose given that the saw device would only work in contact with mineralized bone.The surgeon reported that he was using the burr with the transverse saw device for reducing the dorsum and thought that the end of the saw device appeared to have caused the burn to the skin.As a result, the patient ended up with a burn scarring and would require a second operation.The surgeon further reiterated that it was difficult at this stage to know the degree of recovery that could be expected as it would certainly require monitoring over the next two years and a revision surgery.It was not reported if a spare device was available for use.There was patient involvement reported.There was patient harm that resulted in a medical intervention and prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

During subsequent follow-up with the reporter, additional information was obtained.The reporter stated that the piezo saw device was used as part of a rhinoplasty to reduce the dorsal hump and also to carry out the lateral osteotomies.There was no other procedure than the rhinoplasty.It was further reported that the surgery was not prolonged as a result of this event as the burn was noted quite later on in the procedure.According to the surgeon, the patient¿s current condition was that they had a burnt scar on the left side of their nose, which was dark, thin, atrophic and extremely noticeable.In that regard, there absolutely was a severe permanent and lasting impact to the patient who was aware of the scar every moment of the day.The surgeon further stated that, they were in the process of managing the patient¿s scar and the patient would have to undergo a scar revision at some point in the future.It was further reported that at the time of the surgery, there was nothing unusual about the saw function, the saw pieces or the efficacy of the saw in treating the osteotomy or the dorsal hump.The reporter also indicated that the individual saw pieces were discarded and therefore would not be returned for further investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional information: describe event or problem: during subsequent follow-up with the reporter, additional information was obtained.The reporter stated that the surgeon performed a revision surgery on the patient on (b)(6) 2018.The patient¿s outcome was not yet known.It was further reported that a long scalpel device was also used at the time of the injury.The product code was unknown in the initial report.Therefore, the brand name, common device name, catalog number and 510k classification were unknown.The device information was identified and has been updated accordingly.The udi has been updated accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

During subsequent follow-up with the customer additional information was obtained.The reporter clarified that there were scalpel devices that were also used at the time of the injury.Therefore, the event numbering is being updated to report 1 of 3 for the same event.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

During subsequent follow-up with the customer additional information was obtained.The reporter stated that the procedure chosen for the rhinoplasty was an open approach.It was further reported that the patient recently had a revision surgery which was in the early stages.It was reported that it currently looked as though the depressed element of the scar was much improved; however, the scar was still at this stage, young, a little red and inflamed.The reporter indicated that they believed it would take at least six months before they were able to comment on how significant the improvement had been.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional information: describe event or problem: the medical adviser followed up with the surgeon and additional information was obtained.The surgeon reported that the patient was a (b)(6) female whom underwent an elective rhinoplasty.The surgeon felt that the piezo system was revolutionising that type of surgery, as he had been impressed at the ability to reduce the dorsal hump.The surgeon reported that many surgeons were now switching to this system.It was further reported that the lesion was a full thickness burn on the left side of the nose, lateral to the dorsal hump.That was managed as full thickness burn and left to eschar.Over the following months the eschar resulted a prominent scalloping of the left side of the nose and the patient underwent a second procedure.The surgeon reported not having been on a formal training cadaveric based course for the instrument, but, had been to a number of symposia where ¿(b)(6)¿ had spoken positively about it and he undertook his first case under the observation of the depuy synthes representative.He reported that the patient was his second case.According to the surgeon, getting each procedural step was not possible.He reported having to make a slightly larger incision than for traditional methods, but, was happy to do so due to the good reduction in the dorsal hump it provided.He dissected down and flared open the soft tissues.Then he used a continuous sweeping motion to shave down the dorsal hump and used continuous irrigation whilst to do so.It was further reported that the injury occurred while using the device to shave the dorsal hump.The surgeon further reported that he believed he used the smaller scalpel tip for the removal of the dorsal hump.The surgeon when on to explain which step and with which tip the burn happened.He reported that he shaved the dorsal hump by moving the instrument (407s) back and forth until desired reduction was achieved and while he was doing this, he noticed smoke coming from the soft tissue (like diathermy smoke) from the side of the dorsal hump.It was reported that its then that he noticed the full thickness of the burn in the left side of the nasal soft tissue.The surgeon reported that there was no obvious reduction in irrigation flow or cessation of irrigation.He queried whether despite the saw being in direct contact with bone, if the edge of the tip was in contact with soft tissue could a burn be caused because of; (a) mechanical vibration of the tip against the skin, (b) heating up of the tip which may be in contact with soft tissue and, (c) irrigation doesn¿t run sufficiently into the periphery where the scalpel tip may be in contact with soft tissue.Regarding the amount of liquid used for each step, it was reported that the surgeon was unable to quantify as they did not measure how much fluid was used during the surgery.According to the reporter, the records of procedure was not able to be viewed as notes at another hospital; therefore, they were unable to quantify the flow rate of the irrigation (that was unlikely to be recorded).The surgeon reported that he reported no obvious reduction or noticeable issue with the irrigation which he reported using continuously.The surgeon reported that the tips had been used once as they had them as single use instruments.It was reported that the devices were not available for investigation because they had been disposed of and not possible to retrieve.The surgeon was pragmatic that without the device / tip it was not possible to know if it was used in error, or, if there was an issue with that tip.He reported that he continued to use the hand device and had no issues.He had also had no further issues while using those tips; although he had now become selective with which patients he uses the device with, due to this experience.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): N/I; n/i; N/I
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7252401
• MDR Text Key: 99375002
• Report Number: 8030965-2018-50890
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.000.424S
• Device Lot Number: 0874785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR