MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOSORB LS 1.3MM 1 PIN KIT; ABSORBABLE, FIXATION

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Wound Dehiscence (1154); Pain (1994); Ulcer (2274)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a month post op with the orthosorb pin coming through the skin.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided photographs and medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown root cause was unable to be determined.Medical identified no contributing factors of the event.Pain was noted in the left toe with absorbable pin protruding out of wound; the pin was removed, cultures taken, and dressing applied.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ORTHOSORB LS 1.3MM 1 PIN KIT
• Type of Device: ABSORBABLE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11876760
• MDR Text Key: 252629878
• Report Number: 0001825034-2021-01525
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• PMA/PMN Number: K140625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: 110010741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention