MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX MULTI-PIN CLAMP MR-CONDITIONAL / 6-POSITION; APPLIANCE, FIXATION, NAIL

Model Number	390.002
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: lxt.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 an unknown date, the clamp part of the multi-pin clamp and attachment have not come to a complete stop when tightening on to the carbon fiber rod.The defective clamps were replaced with non-properly functioning clamps.Procedure outcome and patient status are unknown.Concomitant devices: carbon fiber rod (part: unknown, lot: unknown, quantity: 1).This report is for a large ex-fix multi-pin clamp.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.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.Device history record review: part number 390.002.Lot number: h800855.Date of manufacture: 02/15/2019.Place of manufacture: brandywine.Part expiration date: n/a.List of nonconformances: none.Description of dhr review: 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 action.Investigation summary: the large ex-fix multi-pin clamp mr-conditional/ 6-position (part # 390.002, lot # h800855, mfg # 15-feb-2019) was received at us cq with some discoloration on the device.The device was in the assembled state and showed minimal signs of wear.The carbon fiber rods were not returned to us customer quality.However, a functional test was performed on the device to test if the screws that hold the carbon fiber rods were functioning as intended.The screw that would hold the carbon fiber rod was able to be tightened and loosened.However, the screw that is in place to hold the post clamp was very tight and could not be loosened.The post clamp is supposed to be able to rotate so that the carbon fiber rods can be adjusted and then tightened in place.The complaint is confirmed since the post clamp isn't able to move freely.A dimensional inspection was not able to be performed due to the received condition.Device drawings were reviewed with no findings.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: LARGE EX-FIX MULTI-PIN CLAMP MR-CONDITIONAL / 6-POSITION
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8605476
• Report Number: 2939274-2019-57990
• Device Sequence Number: 3030042
• Product Code: KTT
• UDI-Device Identifier: 10886982197795
• UDI-Public: (01)10886982197795
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122455
• 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,Followup
• Report Date (Section B): 04/15/2019

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: 390.002
• Device Catalogue Number: 390.002
• Device Lot Number: H800855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 06/11/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/11/2019; 06/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS