MAUDE Adverse Event Report: SYNTHES BETTLACH TI MATRIXNEURO SCREW SELF-DRILLING 5MM¿STERILE; BONE PLATE

Catalog Number 04.503.105.01S

Device Problems Failure To Adhere Or Bond (1031); Break (1069); Difficult to Insert (1316)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information was requested but has not been received as of the date of this report submission.Implant and explant dates were not provided by reporter.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event the united kingdom as follows: it was reported that an unknown quantity of matrix plates and screws broke post-operatively and were explanted during revision surgery.This report is 5 of 7 for (b)(4).

Manufacturer Narrative

Additional narrative: device is expected to be returned for manufacturer review/investigation, but has yet to be received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update, 05 oct.2015: statement removed from complaint description regarding "this case being revision surgery." the ta noted that this event occurred intraoperatively.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device was used for treatment, not diagnosis if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Product investigation summary: the overall complaint condition is confirmed as the plates were received showing bending.However, the complaint condition for the screws is unconfirmed as the returned screws were intact and functional.The type and extent of deformation present on the returned plates is consistent with damage caused by rough handling outside the recommended technique.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The plates were received showing observable tool marks and bends.One plate showed deformation to one screw hole.The next plate showed bends over the middle length of the plate and in the middle of each screw hole.The third plate shows significant marks and two bends.The bends are each approximately 45 degrees upward and located in the middle length of the plate and at the base of one screw hole.The screw hole at the bend also shows significant deformation.Thus, the complaint condition is confirmed and consistent with the reported condition.The screws were received with deformation consistent with implant and explant.The drive mechanisms each showed wear consistent with having withstood significant torque.There is residue noted on one screw.Thus, as no functional issue was identified, the complaint conditions for these specific devices are unconfirmed and could not be replicated.Review of the design drawing for the plates and for the screws was performed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device reportedly malfunctioned intra-operatively and was not implanted or explanted.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clarification to october 5, 2015 update: the matrix screw head (reportedly) broke on two occasions while the surgeon was inserting the screw into the plate.The fragments of the broke piece(s) could not be retrieved from the bone.The matrix dog bone plate was also so soft that it was bending.As a result, the patient's bone flap was sinking on to the brain.Immediate action taken included screw and dog bone plate removal.The surgeon used a craniofix buttons instead.One screw head remains in the bone flap.The screws and dog bone plates were not strong enough to fix the bone flap back; dog bone plate easily bent and screw head snapped off.The surgery was not prolonged.

• Brand Name: TI MATRIXNEURO SCREW SELF-DRILLING 5MM¿STERILE
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5064535
• MDR Text Key: 25280146
• Report Number: 9612488-2015-10460
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK042365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.105.01S
• Device Lot Number: 9541033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention