MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.046
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Unknown.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.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 the percutaneous insertion handle was discovered damaged in sterile processing.There was no patient involvement.Sales consultant tried to put an 8mm protection sleeve through the targeting hole of the insertion handle and it would not fit.The insertion handle cannot be used in any procedures.The insertion handle is likely bent right at the targeting hole.The sales consultant tried several protection sleeves on the reported insertion handle and they would not fit through the targeting hold.The same protection sleeves were used on a different insertion handle and all of the protection sleeves fit.The issue appears to be with the insertion handle and not the protection sleeves.Concomitant device reported: 12.0mm/8.0mm protection sleeve 188mm (03.010.063, lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 03.010.046, lot no.: 9598388: manufacturing location: (b)(4), release to warehouse date: 11.Dec.2015: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.The percutaneous insertion handle (03.010.046) is routinely used during the insertion of femoral and tibial nails including those in the titanium cannulated retrograde/antegrade femoral nail system technique guide and the suprapatellar instrumentation for titanium cannulated tibial nails system technique guide among others.The returned insertion handle was examined and the complaint condition was able to be confirmed as a burr was noted on the distal end of the 120 degree antegrade locking hole which would inhibit the insertion of a protection sleeve as noted in the complaint description.No definitive root cause was able to be determined, however the failure mode is typically associated with wear and tear for a multiuse device.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.The 120 degree antegrade locking hole inner diameter was checked with a gauge pin and the complaint condition was able to be replicated as the burr inhibited the 12.00mm pin from passing through the distal end of the hole.The largest pin which was able to pass completely through the hole was 11.95mm which is under the minimum specification of 12.00mm 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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7138544
• Report Number: 8030965-2017-50911
• Device Sequence Number: 1068987
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)9598388
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 03.010.046
• Device Lot Number: 9598388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1