MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW GAMMA3® 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200090
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Nonetheless, based on the information provided, it could be concluded that the root cause of the reported event was an user related issue.Hcp failed to sterilize the device prior to the surgery.Reusable devices should always be properly sterilized prior to every surgery.As a reminder, the instructions for use clearly state that: "¿ in the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.The healthcare facility has final responsibility for the implementation of validated procedures to achieve cleanliness and sterility of reusable devices." 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.
Event or Problem Description
As reported: "during a gamma 3 surgery, it was discovered that two nail holding screws had not been sterilized just prior to the surgery.The patient was already under lumbar anesthesia, but hospital rules required that the surgery be postponed to tuesday because of the three-hour sterilization process.Damage from unnecessary anesthesia, postponement of surgery.".

• Brand Name: NAIL HOLDING SCREW GAMMA3® 8X35MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18850640
• Report Number: 0009610622-2024-00092
• Device Sequence Number: 7439358
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 13200090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female