MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS; MISC ORTHO SURGICAL INSTR

Model Number	358.696
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a humeral expert nail system procedure on (b)(6) 2019, the spiral blade inserter would not fit through the aiming arm.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.This report is for one (1) spiral blade inserter for ti humeral nails.This is report 1 of 2 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.The spiral blade inserter (p/n 358.696 lot h413510) was returned and received.The two prongs with alignment tabs on the blade guide shaft was observed to be slightly bent outwards, away from the center of axis.No other issues were identified with the returned components of the device.Functional test: a functional test was attempted by advancing/inserting the returned spiral blade inserter in the returned spiral blade aiming arm.The inserter would not advance into the aiming arm as intended.The complaint was able to be replicated as the returned spiral blade inserter would not advance/insert into the returned aiming arm.Measurements of returned instrument: distance between the two alignment tabs: 11.42 mm, non-conforming.Inside diameter between the two alignment tab prongs.7.31 mm, non-conforming.The complaint is confirmed for the received spiral blade inserter (p/n 358.696 lot h413510) as the two prongs with alignment tabs on the blade guide shaft was observed to be slightly bent outwards, away from the center of axis.Additionally a functional test displayed that the inserter would not advance into the aiming arm as intended.There is no indication that a design or manufacturing issue contributed to the complaint.The inability to assemble the guide shaft into the aiming arm is due to the prongs of the guide shaft bending outward.While no definitive root cause could be determined for the bending of the prongs, it is possible that the device encountered unintended forces such as impact against hard surface.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 358.696.Synthes lot # h413510.Supplier lot # h413510.Release to warehouse date: 09 oct 2017.Supplier: avalign technologies - nemcomed.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this 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.
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.The device has been 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.

• Brand Name: SPIRAL BLADE INSERTER FOR TI HUMERAL 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: 8322733
• Report Number: 2939274-2019-56377
• Device Sequence Number: 16525607
• Product Code: LXH
• UDI-Device Identifier: 10886982196835
• UDI-Public: (01)10886982196835
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2019

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: 358.696
• Device Catalogue Number: 358.696
• Device Lot Number: H413510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 05/31/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/16/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1