MAUDE Adverse Event Report: STRYKER GMBH PIP BROACH, MIDDLE, SIZE 30 SILICONE PIP; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number 170863

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The following event was reported: "during pip silicone ancillary use: small metal debris were observed when using proximal and distal raps".We observed metal debris as soon as the proximal rasps 30 and 40 and the distal rasps 20 and 30 were impinged.

Event Description

The following event was reported: "during pip silicone ancillary use: small metal debris were observed when using proximal and distal raps" we observed metal debris as soon as the proximal rasps 30 and 40 and the distal rasps 20 and 30 were impinged.

Manufacturer Narrative

The reported event that pip broach, middle, size 30 silicone pip was alleged of 'contamination of the device' could be confirmed based on pictures sent and the returned devices.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by poor handling together with the normal wear of the devices.These particles found, if returned, were going to enable a deep analysis of their nature.Based on the pictures sent, some black particles are noticed on the white dressing.Moreover, the parts were returned and therefore were inspected visually and with the microscope.However, these particles weren't found.The microscope investigation showed that the tip of the rasps has some broken edges.Most probably, the particles are these small broken edges coming from the tip of rasps.Such an incident (broken edges) can occur if the parts are handled with violent forces.Moreover, these devices were released on 2015/2016, therefore, at least 3 years prior the incident.The normal wear of the devices is part of their life cycle.Therefore, this case is classified as a user related issue.Aa review of the device history for the reported lot did not indicate any abnormalities.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 any further information is provided, the investigation report will be updated.

Manufacturer Narrative

Corrections to concomitant medical products and device evaluated by mfr.The reported event that pip broach, middle, size 30 silicone pip was alleged of 'contamination of the device' could be confirmed only based on pictures, since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history for the reported lot did not indicate any abnormalities.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 Description

The following event was reported: "during pip silicone ancillary use: small metal debris were observed when using proximal and distal raps" we observed metal debris as soon as the proximal rasps 30 and 40 and the distal rasps 20 and 30 were impinged.

• Brand Name: PIP BROACH, MIDDLE, SIZE 30 SILICONE PIP
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8453846
• MDR Text Key: 140144857
• Report Number: 0008031020-2019-00323
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021287
• UDI-Public: 00886385021287
• Combination Product (y/n): N
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170863
• Device Lot Number: 15234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other