MAUDE Adverse Event Report: SYNTHES TUTTLINGEN HOHMANN RETRACTOR 24MM LONG WIDE TIP 270MM

Catalog Number	399.28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an original surgery for a hip replacement on (b)(6) 2017, as the surgeon was retracting the tissue away from the hip bone with a hohmann retractor, the metal instrument broke in half.No fragments were generated.Another retractor was available in the operating room to complete the procedure.There was no surgical delay reported.The surgery was completed successfully with the patient in stable condition.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Date returned to manufacturer subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Device returned to manufacturer.A device history record (dhr) review was performed on item 399.28/lot # a7aa013: dhr not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.A product development investigation was performed on the subject device.A visual inspection and drawing review were performed as part of this investigation.The 399.28 lot number a7aa013 hohmann retractor was returned and reported to have broken intraoperatively.This condition is confirmed; the device was returned broken in two halves with a slight bend to both pieces.This complaint condition was likely caused by frequent repeated use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 399.28 hohmann retractor is an instrument routinely used in the hip preservation surgery set per relevant technique guide.The balance of the returned device is in fairly worn condition with several markings and signs of superficial wear.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HOHMANN RETRACTOR 24MM LONG WIDE TIP 270MM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• MDR Report Key: 6461218
• Report Number: 1719045-2017-10287
• Device Sequence Number: 18952345
• Product Code: GAD
• UDI-Device Identifier: 10886982202659
• UDI-Public: (01)10886982202659(10)A7AA013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2017

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: 399.28
• Device Lot Number: A7AA013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/25/2017; 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1