MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE, COMP/POLYAX 2.6MM DRILL, T10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703882
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
The reported event could be confirmed, since the orange color coding is partially missing as complained.The device inspection revealed the following: the visual inspection of the drill guide has shown that the orange color coding is on both sleeves peeled off as complained, just one marking is still present.The laser markings of the device are slightly faded, the reported catalog- and lot number can be confirmed.The inspection of the slots with the missing color coding has shown that there are wear marks in this area visible, the marks are an indication for contacts with other instruments, for example during reprocessing.A review of the device history for the reported lot did not indicate any abnormalities, the device was manufactured in (b)(6) 2018 according to the specification.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The event was caused by normal wear and tear combined with contacts with other instruments during reprocessing over the years.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 10993-1 (biological evaluation of medical devices) and was found to be biocompatible as required.If more information is provided, the case will be reassessed.
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 2.6MM 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: 16837860
• Report Number: 0008031020-2023-00167
• Device Sequence Number: 6889016
• Product Code: LXH
• UDI-Device Identifier: 07613327069921
• UDI-Public: 07613327069921
• 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): 08/24/2023

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: 703882
• Device Catalogue Number: 703882
• Device Lot Number: AJ01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/02/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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