MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PUSH-PULL REDUCTION DEVICE; GUIDE

Model Number	324.024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary.Investigation flow: damage.The push-pull reduction device (p/n: 324.024, lot #: pe00893) was returned and received at us cq.Upon visual inspection, it was observed that the drill shaft was broken at the most proximal thread and the broken fragment was not returned.No other issues were observed with the returned device.The device failure/defect was identified.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The device received was broken.Hence confirming the allegation.The complaint condition was confirmed for the push-pull reduction device (p/n: 324.024, lot #: pe00893).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot.Part # 324.024.Synthes lot # pe00893.Supplier lot # pe00893.Release to warehouse date: dec 20, 2010.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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.
Event or Problem Description
It was reported that during a routine incoming inspection of a loaner set at (b)(6) site on an unknown date, the push-pull reduction sleeve was broken.There were no patient and surgical involvement reported.This complaint involves one (1) device.This report is for (1) push-pull reduction device.This report is 1 of 1 for (b)(4).

• Brand Name: PUSH-PULL REDUCTION DEVICE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11902238
• Report Number: 2939274-2021-02663
• Device Sequence Number: 17031914
• Product Code: FZX
• UDI-Device Identifier: 10886982190963
• UDI-Public: 10886982190963
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 324.024
• Device Catalogue Number: 324.024
• Device Lot Number: PE00893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1