MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.108.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a j&j 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 an unknown date, the unknown wires would not pass through two (2) pediatric hip guiding blocks.The issue was discovered during the routine inspection while restocking the instrument.There was no patient involvement.This report is for one (1) pediatric lcp hip plate guiding block for 3.5mm screws.This is report 1 of 2 for complaint (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.Part: 03.108.001-us.Lot: 8083984.Manufacturing site: bettlach.Supplier: n/a.Release to warehouse date: 18 october 2012.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the ped lcp hip pl guiding block 3.5 scrs (part #: 03.108.001, lot #: 8083984) was received at us customer quality (cq).Upon visual inspection of the complaint device, it was noticed that there were scratches inside the holes of the block and nicks around the edges of the holes.One of the two parallel holes appeared to be slightly deformed at the front end.Functional test: a functional assessment was not performed with the complaint device since the applicable wire was not returned.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: since there were scratches and nicks inside and around the edges of the holes of the block of the devices, an accurate measurement of the device could not be obtained; hence no dimensional inspection was performed.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as scratches and nicks were observed inside and around the edges of the holes of the blocks.One of the two holes at the front end of the block appears to be slightly deformed.This condition could contribute to the wire not being able to pass through the hole causing the device interaction problem.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12421527
• Report Number: 2939274-2021-05164
• Device Sequence Number: 3528031
• Product Code: FZX
• UDI-Device Identifier: 10886982071514
• UDI-Public: (01)10886982071514
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 03.108.001
• Device Catalogue Number: 03.108.001
• Device Lot Number: 8083984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE