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

Model Number	03.108.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The instrument(s) was not returned and instead the investigation will be done based on the received image(s).The image(s) was reviewed, and the complaint condition could not be confirmed as the image provided shows the aiming block assembled with other instruments.As the instrument(s) was not returned, an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that un an unknown date, wires were getting caught in guides.The guides required replacement.There was no reported patient consequence.This report is for a pediatric locking compression plate (lcp) hip plate guiding block for 3.5mm screws.This is report 1 of 2 for (b)(4).

• Brand Name: PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10513732
• Report Number: 2939274-2020-04060
• Device Sequence Number: 3316639
• Product Code: FZX
• UDI-Device Identifier: 10886982071514
• UDI-Public: (01)10886982071514
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1