MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1832-1035S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the following: upon attempting explantation, one of the distal locking pins was found to be cold welded.The bolt had to be exposed ventrally and dorsally and milled off so that the nail could be knocked out of the medullary canal.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The product return and lot code were requested several times but to no avail.All attempts, as required per procedure, were made to try to obtain the affected item for physical examination; additionally, an extra effort was made in march 2022.Known from another case ¿cold welding¿ due to friction corrosion being caused by high surface pressure.Most likely high surface pressure generated by high load applied to the items in question had led to the reported event.Local surface pressure may arise when the items are assembled under misalignment.Nevertheless, whether the parts in question are affected by cold welding could not be confirmed due to missing physical item and thus, further technical statement is impossible.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 [ifu, optech] did not indicate any abnormalities.No indications of material, manufacturing or design related problems could be verified based on current information available.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
The customer reported the following: upon attempting explantation, one of the distal locking pins was found to be cold welded.The bolt had to be exposed ventrally and dorsally and milled off so that the nail could be knocked out of the medullary canal.

• Brand Name: PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12743585
• Report Number: 0009610622-2021-00771
• Device Sequence Number: 4351092
• Product Code: HSB
• UDI-Device Identifier: 04546540515414
• UDI-Public: 04546540515414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 1832-1035S
• Device Catalogue Number: 18321035S
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female