MAUDE Adverse Event Report: ZIMMER GMBH AWL

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device for review.X-ray pictures were received and will be reviewed within the investigation.A lot number was received for the device, the device history records will be reviewed within the investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that during surgery, the awl broke in two.One part was left in the patient.

Manufacturer Narrative

A technical investigation was not possible to perform, as the devices were not at hand.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: no trend identified.Device history records (dhr): at zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it is reported that the "handawl for reaming ms 30" broke in two parts, one part is left in the patient.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: parts were 100% visually inspected (in the year 1998).Conclusion summary: cutting and drilling instruments are categorized as ¿external communicating devices¿ with "tissue/bone" contact for less than 24 hours.Due to the fact that a part of the instrument stayed in the body, patient has to be monitored.The instrument was in use for around 18 years.Therefore the most likely root cause is that the function of the blades was not given anymore due to long term use / excessive use (wear).Additionally, according to the ifu: "if damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for replacement." however, an exact root cause could not be determined.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: AWL
• Type of Device: AWL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6029496
• MDR Text Key: 57812160
• Report Number: 0009613350-2016-01265
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 72.00.35
• Device Lot Number: 9207
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other