MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ORTHOLOC PIN PULLER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18770140
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that "the stryker sales rep reported that the pin puller did not engage pins.There was a 20 second delay in the case.The case was completed using a pin holder from another set.".
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg) and h3(device code).The reported event could not be confirmed as inspection of the returned device did not confirm the alleged failure.Functional and visual inspection revealed: the tests performed did not reproduce the reported issue, the pin puller engages correctly with the pin under normal operating conditions.Additionally, all components, including the spring mechanism, appear to be functioning properly, and no visible damage or abnormal wear was observed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that "the stryker sales rep reported that the pin puller did not engage pins.There was a 20 second delay in the case.The case was completed using a pin holder from another set.".

• Brand Name: ORTHOLOC PIN PULLER
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24205643
• Report Number: 3010667733-2026-00076
• Device Sequence Number: 9635600
• Product Code: LXH
• UDI-Device Identifier: 00840420199720
• UDI-Public: (01)00840420199720(11)210107(10)2762259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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: 18770140
• Device Lot Number: 2762259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 04/29/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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