MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT

Catalog Number 03.123.011

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 Description

It was reported that on an unknown date, insertion guide screw, for the locking compression plate (lcp) periarticular proximal humerus plate broke.It was unknown if there was a procedure or patient involvement.This report is for one (1) insertion guide f/3.5mm lcp periartic prox humerus pl/lt.This is report 1 of 1 for (b)(4).

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.Part manufacturing date: january 04, 2011; part expiry date: n/a; manufacturing location: depuy synthes ¿ elmira; lot: 6557510; part: 03.123.011.Device history record (dhr) review: a review of the dhr revealed no non-conformances.The dhr shows lot 6557510 of insertion guide f/3.5mm lcp periartic prox humerus pl/lt was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the purchased m3 screw for guide block assembly revealed this lot met all specifications with no non-conformances or rework noted.Investigation flow: broken visual inspection: visual inspection of the guide shows minor surface wear and scratches which do not impact functionality.The m3 screw was found to be broken in the threaded portion which agrees with the reported condition.The broken screw tip was not returned.The complaint was confirmed.Drawing/specification review: the device drawings were reviewed during investigation.Dimensional inspection: the major thread diameter of the remaining threaded portion was measured to be 2.91mm which is within the specification of m3 (2.980 to 2.874); measured using mitutoyo micrometer.Material/hardness review: a review of the purchased m3 screw for guide block assembly revealed this lot met all specifications with no non-conformances or rework noted.Further material review could not be performed as this is a supplied part.No definitive root cause was able to be determined.However excessive torque on the screw may have contributed to the condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.

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 was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history record (dhr) review has been requested.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: INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7794718
• MDR Text Key: 117847861
• Report Number: 2939274-2018-53362
• Device Sequence Number: 1
• Product Code: FXZ
• UDI-Device Identifier: 10886982074942
• UDI-Public: (01)10886982074942
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.123.011
• Device Lot Number: 6557510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1