MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED CONICAL BOLT FOR 10MM-14MM UNIV TIBIAL NAILS; MISC ORTHO SURGICAL INSTR

Model Number	355.44
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, during evaluation in the loaner department, it was found that threaded conical bolt was not functioning and stuck to a non depuy synthes product part number 04.004.049.There was no patient involvement this report is for one (1) threaded conical bolt for 10 mm-14 mm univ tibial nails.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H3: h6: it was reported that on (b)(6) 2019, during evaluation in the loaner department, it was found that threaded conical bolt was not functioning and stuck to a non depuy synthese product part number 04.004.049.There was no patient involvement.Flow: device interaction/functional please note the part number of the nail stated in the complaint description is incorrect after visual inspection the part number is 04.004.649 please note pictures and the physical product was returned and an investigation will be completed using both pieces of evidence.Visual inspection of the returned device performed at customer quality (cq) showed that the conical bolt (part of the universal nail system) is stuck to an expert tibial nail (part number: 04.004.469) and could not be removed.Based on the damage to the nail it appears the bolt was used to aid in the removal of the nail.Functional testing was not performed because the bolt is part of the universal nail system and the nail is part of the expert tibial nail system and the systems are not interchangeable.A dimensional inspection was not performed for the reasons stated above.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing records showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.No definitive root cause could be determined, most likely the bolt was used to remove the nail and the force required to remove caused the parts to get stuck to each other.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Part: 355.440 lot: 8586562 manufacturing site: bettlach release to warehouse date: 20.Sep.2013 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.

• Brand Name: THREADED CONICAL BOLT FOR 10MM-14MM UNIV TIBIAL NAILS
• 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: 8893305
• Report Number: 2939274-2019-59819
• Device Sequence Number: 1400497
• Product Code: LXH
• UDI-Device Identifier: 10886982194985
• UDI-Public: (01)10886982194985
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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 Model Number: 355.44
• Device Catalogue Number: 355.44
• Device Lot Number: 8586562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1