MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE POLY INSERT TOOL 2L W/ ATTACH SCREW HOUSING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	100063102
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the size 2 poly inserter is ¿tighter¿ when inserting the poly and harder to twist.The procedure was completed successfully.
Event or Problem Description
It was reported that the size 2 poly inserter is ¿tighter¿ when inserting the poly and harder to twist.The procedure was completed successfully.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection revealed the following: a device inspection of the affected device was not possible since the affected device was not returned and no other evidences were provided for investigation.However, a poly insertion tool with the same reported catalog number was obtained from the kitting team for inspection.Visual examination of the poly insertion tool shows no signs of significant deformation or defects that could impair the functionality of the device.During functional testing, the poly insertion tool was assembled with a nut screw, a jack screw, a size 2 plunger block and a size 2 poly implant.The size 2 poly implant was loaded onto the poly insertion tool by sliding into the dovetail of the device.The reported issue could not be confirmed as no problems were noted during the assembly of the devices.The poly implant was able to fit into the poly insertion tool without any noticeable resistance or difficulty.Key dimensional measurements of the poly insertion tool were taken with a digital caliper and found to be within specifications.The root cause of the reported issue could not be conclusively determined.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INBONE POLY INSERT TOOL 2L W/ ATTACH SCREW HOUSING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18727889
• Report Number: 3010667733-2024-00082
• Device Sequence Number: 6276391
• Product Code: LXH
• UDI-Device Identifier: 00889797029858
• UDI-Public: 00889797029858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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 Catalogue Number: 100063102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown