MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 PROX. HUM.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-2035
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that the surgeon tried to drill and insert the screw to the fourth screw hole from the proximal side of t2ph nail, but the screw entered in front of the nail, not into the hole.The surgeon eventually gave up inserting the fourth screw.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported that the surgeon tried to drill and insert the screw to the fourth screw hole from the proximal side of t2ph nail, but the screw entered in front of the nail, not into the hole.The surgeon eventually gave up inserting the fourth screw.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12277649
• Report Number: 0009610622-2021-00630
• Device Sequence Number: 4494830
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/08/2021

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: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 11/08/2021
• 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