MAUDE Adverse Event Report: STRYKER GMBH DEPTH GAUGE FOR SCREWS: Ø2.7/3.5/4.0MM; SCREW, FIXATION, BONE

Catalog Number	702876
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
During pelvic surgery the long inner port of 702877 was inserted in the outer port of 702876 which resulted in a too long measurement.During insertion of the screw the mistake was detected.Customer stated that there is no number on the inner port to verify which ports of the 2 devices belong together.Surgical delay of 5 min.Not longer.No other consequences reported.The customer stated that there is a possibility of hazard if wrong measurement is not detected.In this case patient was not harmed.
Additional Manufacturer Narrative
The reported event that depth gauge for screws: 2.7/3.5/4.0mm was alleged of 'customer unsatisfied' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The sales reported that after sterilization of the two mentioned sets only 3 parts came back, the inner part of the long set (702877) was missing.Based on the given information, the root cause was attributed to be user related.The failure was caused by user error.The device inspection revealed the following (test sets only): note that no devices were returned for investigation, nevertheless the attached image documentation will explain how these two device sets should be used: (pictures taken from our test set).Two different instrument sets; top (short) for 2.7/3.5/4.0mm and bottom (long) for 4.5/6.5mm screws.The diameters which are engraved in both inner and outer parts on either set are clearly sufficient in order to differentiate these devices.Therefore please ensure to check this prior us in order to eliminate any confusion.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During pelvic surgery the long inner port of 702877 was inserted in the outer port of 702876 which resulted in a too long measurement.During insertion of the screw the mistake was detected.Customer stated that there is no number on the inner port to verify which ports of the 2 devices belong together.Surgical delay of 5 min.Not longer.No other consequences reported.The customer stated that there is a possibility of hazard if wrong measurement is not detected.In this case patient was not harmed.

• Brand Name: DEPTH GAUGE FOR SCREWS: Ø2.7/3.5/4.0MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8126098
• Report Number: 0008031020-2018-01022
• Device Sequence Number: 11000297
• Product Code: HWC
• UDI-Device Identifier: 04546540413895
• UDI-Public: 04546540413895
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 702876
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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