MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE, COMP/POLYAX 2.0MM DRILL, T10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703883
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "orif for left clavicle was performed.When an operating room staff checked the used instruments after postoperative cleaning, it was found that color paint (green or orange) of the two drill guides (cat#703882, 703883) had peeled off.It was unknown when the paints peeled off.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were 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.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.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.The complaint was forwarded to r&d to provide a feedback related to the questions of the user with following result: the color coding is made out of a two component color which consists of 2-butoxy-ethylacetat (color) and aliphatic polyisocyanate (hardener).The color was tested based on norm iso (b)(4) (biological evaluation of medical devices) and was found to be biocompatible as required.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
As reported: "orif for left clavicle was performed.When an operating room staff checked the used instruments after postoperative cleaning, it was found that color paint (green or orange) of the two drill guides (cat#703882, 703883) had peeled off.It was unknown when the paints peeled off.".

• Brand Name: DRILL GUIDE, COMP/POLYAX 2.0MM DRILL, T10
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16837870
• Report Number: 0008031020-2023-00168
• Device Sequence Number: 15175745
• Product Code: LXH
• UDI-Device Identifier: 07613327069938
• UDI-Public: 07613327069938
• 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,Followup
• Report Date (Section B): 08/02/2023

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: 703883
• Device Catalogue Number: 703883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/02/2023
• 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