MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN SAW BLADES; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number UNK-SAW-BLADES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Udi: the part number was unknown.All attempts to obtain product information were unsuccessful.Therefore, udi is unavailable.The brand name, catalog number and serial number were unknown.The manufacturing location was unknown.Pma/510(k) number was unknown the serial number / lot number was unknown; therefore, the device manufacture date was unknown.Concomitant med products and therapy dates: small battery drive device, (b)(6) 2019.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, while using an unknown saw device, it was discovered that one of the patient's arteries was punctured.According to the reporter, a different saw device was sent from the one that had been requested by the user, who in turn chose to use it together with the small battery drive device.It was reported that the set was inappropriate for use.The hospital's cardiovascular team managed to contain the bleeding and it was reported that the patient was doing well.The reporter indicated that during the investigation, it was identified that the customer request form did not detail the need for the device to be a reciprocating saw device as indicated for the surgery.It was reported that the team requested a reciprocating saw device for surgery and the saw devices were sent.However, the handpiece / motor device that was required to be used with the saw was not sent.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.There was medical intervention or prolonged hospitalization associated with this event.The reporter did not allege any malfunction against the devices used in the procedure.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.During subsequent follow-up with the customer, additional information was obtained.The reporter clarified that the event occurred during a knee osteosynthesis procedure.It was reported that to support an osteosynthesis surgery, two different kits should have been sent, one kit containing the saw blade devices and another one with the adapter device (handpiece).In this event, only the saw blade kit was sent to the hospital.The user decided to use another saw blade device that was inappropriate for the surgery, which was also manufacturer¿s product.It was reported that, the material was part of the instrumentals that were already in the possession of the hospital and was not part of the kit that was sent.It was reported that during the surgical procedure, when using the saw device, one of the patient's arteries was punctured.The hospital's cardiovascular team managed to contain the bleeding.The patient was hospitalized for four days in the intensive care unit (icu) to wait for the results and the return of the perfusion and circulation in the vessel reached by the blade.It was reported that the patient was discharged and was doing well.It was reported that the patient was a female.The reporter indicated that the hospital discarded the device after surgery.It was further reported that the device fits into the oscillating saw attachment device.The oscillating saw attachment device has been included in this event and added as part of the concomitant medical products.Concomitant med products and therapy dates: oscillating saw attachment device, (b)(6) 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: UNKNOWN SAW BLADES
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9356344
• MDR Text Key: 181465809
• Report Number: 8030965-2019-70258
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-SAW-BLADES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention