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 Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Facility telephone is not available for reporting.Initial reporter is synthes sales consultant.(b)(4).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 12.0mm/8.00 mm protection sleeve will not insert through the hole labeled ¿120 degrees¿ on the percutaneous insertion handle.There is no patient or procedure involved.This report is for one (1) percutaneous insertion handle.This is report 1 of 1 for (b)(4).
Additional 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.Device history records review was conducted.The report indicates that the: part no.: 03.010.046, lot no.: 1436102, manufacturing location: haegendorf, release to warehouse date: 10.Jul.2006.No 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.Investigation summary: it was reported that the 12.0mm/8.00 mm protection sleeve will not insert through the hole labeled ¿120 degrees¿ on the percutaneous insertion handle.There is no patient or procedure involved.The returned insertion handle was examined and the reported complaint condition was able to be confirmed as post manufacturing damage to the hole was observed.The protection sleeve in question was not returned, as such the complaint condition was unable to be replicated at customer quality (cq).However, the damage is encroaching on the hole diameter and therefore it would cause the reported complaint condition of a protection sleeve not able to be inserted into the hole.The returned insertion handle was manufactured in july 2006 and is over 11 years old.No 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.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings for the returned device were reviewed: the design, materials and finishing processes were found to be appropriate for the intended use of this device.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 and the suprapatellar instrumentation for titanium cannulated tibial nails system among others.No dimensional analysis was performed for the returned device as it is visually confirmed that the hole size is smaller now due to the post manufacturing damage.The most likely root cause for this post manufacturing damage is rough handling during 11+ years of use.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• 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: 7427140
• Report Number: 2939274-2018-51642
• Device Sequence Number: 1453227
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)1436102
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 1436102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1