MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP® DHHS(TM) INSERTER GUIDE

Model Number	338.341
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Occupation: synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on august 15, 2019, during field inspection the following items were found broken: one (1) cable tensioner device has something stuck inside of it preventing proper use, top clip of the two (2) locking compression plate dynamic helical hip system inserter guide were broken preventing proper use, one (1) locking compression plate dynamic helical hip system inserter shaft is not round therefore screw cannot pass through instrument, the handle of one (1) screwdriver t15 cracked, one (1) cannulated hexagonal screwdriver should have round tip therefore screws does not fit, handle of the one (1) small hexagonal screwdriver with holding sleeve was busted, and the tip of the one (1) depth gauge bent.There was no patient involvement.This is report 4 for 5 (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: 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 history lot: part number: 338.341.Synthes lot number: 5099248.Supplier lot number: n/a.Release to warehouse date: 21mar2006.Expiration date: n/a.Manufactured by synthes brandywine.This non-conformance is not relevant to the complaint condition since it is not related to one (1) cable tensioner device has something stuck inside of it preventing proper use, top clip of the two (2) locking compression plate dynamic helical hip system inserter guide were broken preventing proper use, one (1) locking compression plate dynamic helical hip system inserter shaft is not round therefore screw cannot pass through instrument, the handle of one (1) screwdriver t15 cracked, one (1) cannulated hexagonal screwdriver should have round tip therefore screws does not fit, handle of the one (1) small hexagonal screwdriver with holding sleeve was busted, and the tip of the one (1) depth gauge bent.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot.Part number: 338.341, synthes lot number: 5099248, supplier lot number: n/a, release to warehouse date: 21mar2006, expiration date: n/a, manufactured by synthes brandywine.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.

• Brand Name: LCP® DHHS(TM) INSERTER GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9031032
• Report Number: 2939274-2019-60519
• Device Sequence Number: 13926122
• Product Code: FZX
• UDI-Device Identifier: 10886982193384
• UDI-Public: (01)10886982193384
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2019

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: 338.341
• Device Catalogue Number: 338.341
• Device Lot Number: 5099248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 10/08/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/07/2019; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1