MAUDE Adverse Event Report: SYNTHES TUTTLINGEN HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number	03.010.430
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth, weight is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed on part # 03.010.430, lot# t129418: manufacturing date: 16-feb-2016, review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All 16 parts of the lot were checked 100% for critical features and for function at the final inspection on 16-feb-2016.All parts except one were found to be conforming.The non-conforming part was scrapped due to surface finish issue.No non conformance reports (ncrs) were generated during production.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 or Problem Description
It was reported that a patient underwent surgery for a tibia fracture (side unknown) on (b)(6) 2017.During the procedure while the surgeon was treating the patient with a suprapatellar tibia nail and upon exchange of the 12 mm protection sleeve; the sleeve would not release from the suprapatellar handle effectively.The surgeon eventually was able to release the sleeve from the handle by manually pulling the sleeve from the handle with a pair of pliers.The surgeon was unsure as to which device was defective or possibly both.There was a surgical time delay of approximately twenty to thirty (20-30) seconds.There was no additional medical or surgical intervention and no x-rays.The surgery was successfully completed.There was no harm to the patient and the patient status outcome is fine.Concomitant device reported: suprapatellar titanium cannulated tibia nail (quantity 1).This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a product investigation was completed: the 03.010.430, lot number t129418 handle for protection sleeves was returned and reported to not release from the 03.010.435 12.0mm protection sleeve properly.This complaint condition was likely caused by intraoperative conditions preventing the full depression of the release mechanism and proper detachment; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, device history record review, and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 03.010.430 handle for protection sleeves is an instrument routinely used in suprapatellar instrumentation for titanium cannulated tibial nails system.The device was returned and reported to not release from the protection sleeve properly.This condition is confirmed; while the protection sleeve was not returned to test, the lip and proximal portion of the handle show scrape marks and deformation consistent with forcible removal of the protection sleeve.It is likely that intraoperative conditions preventing the full depression of the release mechanism and proper detachment has led to this complaint condition.The device was manufactured in february 2016 and is over a year old.The balance of the returned device is in otherwise fairly good condition without much superficial wear.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6437205
• Report Number: 9680938-2017-10050
• Device Sequence Number: 13595075
• Product Code: JDS
• UDI-Device Identifier: 10886982068712
• UDI-Public: (01)10886982068712(10)T129418
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.430
• Device Lot Number: T129418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIBIA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Age: 56 YR