MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL ROD ASSEMBLY - JAPAN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7650-1956
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Not yet returned.
Event or Problem Description
It was reported that when the fixed pin of the proximal rod assembly was hit in the bone, the pin was broken.The all broken part was removed.
Event or Problem Description
It was reported that when the fixed pin of the proximal rod assembly was hit in the bone, the pin was broken.The all broken part was removed.
Additional Manufacturer Narrative
An event regarding head fracture from the pin involving a scorpio guide was reported.The event was confirmed based on the photo of the device provided.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photograph confirms the presence of "heads" on the pins and that the head of one pin is broken off.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event was confirmed based on the photo of the device provided; the head is broken from the pin.The exact cause of the event could not be determined as the device was not returned for evaluation.Return of the device is needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: PROXIMAL ROD ASSEMBLY - JAPAN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7591509
• Report Number: 0002249697-2018-01777
• Device Sequence Number: 13906829
• Product Code: LXH
• UDI-Device Identifier: 07613327234022
• UDI-Public: 07613327234022
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 7650-1956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other